A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B

ViiV Healthcare

Status and phase: Completed; Phase 4

Conditions: HIV Coinfection

Treatments: Drug: Maraviroc; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01327547

2010-021994-35 (EudraCT Number)

A4001098

Details and patient eligibility

About

To describe liver enzyme elevations in patients who are coinfected with HIV and either Hepatitis C (HCV) and/or Hepatitis B (HBV) receiving maraviroc or placebo in combination with their current suppressive anti-HIV drug therapy.

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV coinfected with HCV and/or HBV.
• Undetectable HIV-1 RNA for at least 3 months prior to the screening visit
• Treatment with current antiretroviral therapy (3-6 drugs excluding low-dose ritonavir) for at least 5 months.

Exclusion criteria

• Currently receiving maraviroc.
• Active opportunistic infections.
• ALT and/or AST >5x upper limit of normal.
• Direct bilirubin >1.5x upper limit of normal.
• Severe or decompensated liver disease.
• Liver disease unrelated to viral hepatitis infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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138 participants in 2 patient groups, including a placebo group

1.0

Experimental group

Treatment:

Drug: Maraviroc

2

Placebo Comparator group

Treatment:

Drug: Placebo